SPDS 09052014

SMPR Key Points:  Determination Method

Analytical range

50 ‐ 200 ppm

Limit of Quantitation (LOQ)

≤ 50 ppm

ry 

Repeatability (RSD r )

≤ 20%

70% to 120% of mean  spiked recovery over the  analytical range 

Single Laborato Validation

Recovery 

Reproducibility (RSD R )

≤ 30%

Multi‐Lab 

Validation

Motion • Move to accept the Standard Method  Performance Requirements for  Screening  Method for PDE5 Inhibitors as presented.